It is a commonly known fact that pharmaceutical companies have suppressed unfavourable research. For example, in 1998, GlaxoSmithKline withheld clinical trial data, which showed that paroxetine (Paxil) was an ineffective treatment for depression in children and adolescents. Another example features GlaxoSmithKline. In an internal company memo, a GlaxoSmithKline employee stated that "It would be commercially unacceptable to include a statement that efficacy had not been demonstrated, as this would undermine the profile of paroxetine". Moreover, internal industry memos were released during litigation against AstraZeneca. These memos revealed that the company withheld data on quetiapine (Seroquel) because its staff were not "...100% comfortable with this data being made publicly available at the present time...however I understand we have little choice...Lisa has done a great 'smoke-and-mirrors; job!" A 1999 AstraZeneca email begged the question, "The larger issue is how do we face the outside world when they begin criticizing us for suppressing data?" Pfizer, Parke-Davis, Merck, and other pharmaceutical companies have also been found to suppress clinical trial data and evidence of safety concerns in order to maintain favourable commercial profiles of their medications.

It is no surprise that a recent investigation by the Toronto Star found that, since 2008, at least 40 Canadian pharmaceutical companies have not only hidden, altered and destroyed data showing that their pharmaceutical products were tainted and unsafe, but also neglected to report evidence of side-effects experienced by patients when taking their medications.

The Star obtained records from the US Food and Drug Administration through the U.S. Freedom of Information Act because the US FDA inspects Canadian and international facilities when drugs that are manufactured in these facilities are intended to be distributed in the United States; however, unlike the FDA, which publicly posts investigation dates and results on its website, Health Canada does not transparently enforce drug manufacturing laws. Therefore, Canadian physicians and the public remain unaware of the problems that are revealed through any Canadian investigation. The FDA website provides dozens of warning letters to Canadian companies, detailing the atrocious conditions in these drug manufacturing facilities. In general, Health Canada conducts only a small fraction of the number of investigations that the FDA conducts.

Canadian generic giant, Apotex, has been cited for not only serious manufacturing violations, but also failing to report undesirable test results, as well as tampering with bacterial growth test records. Since 2008, the FDA has inspected Apotex at least nineteen times. In sixteen of these 19 investigations the FDA found that Apotex employed "objectionable" practices and had "repeated deficiencies". In one case, the FDA indicated that Apotex "failed to uphold 'its legal obligation'". These findings were not challenged by Apotex. Furthermore, the FDA has requested that Apotex investigate whether its middle and top management employees have been involved in data manipulation.

Taro Pharmaceuticals, Canadian generic manufacturer, was cited for keeping drugs on the market even though company testing showed that batches of the medication deteriorated prior to the expiry date indicated on the product label. Cangene Corp., another Canadian drug manufacturer failed to report of side-effects to authorities. These side-effects included, but were not limited to, blood clots and fever associated with their products. Although these findings were a result of US FDA investigation, the report also shows that the same drugs in question would have been prescribed to Canadians as well. Therefore, Health Canada would have been required to investigate these same drug manufacturers, but information about Health Canada's investigations are not made public. Canadian pharmaceutical policy expert Alan Cassels stated that "Health Canada is giving the least amount of information that they can...Instead of actually increasing people's confidence in the system, this kind of secrecy is degrading it." Cassels asks, "What's the reason for all the secrecy?"

Furthermore, the US FDA has instituted import bans on drugs made by Apotex (in India) and Ranbaxy, an India-based generic manufacturer, which also distributes pharmaceuticals to North America. The FDA found that India facilities are supplying Canada with medications that the US FDA knows have been adulterated. Following FDA inspections in 2008, the US government banned imports from two Ranbaxy facilities in India, which also distribute pharmaceuticals to Canada. In 2013, Ranbaxy's US subsidiary paid $500 million in criminal fines ($150 million) and settlements ($350 million) for its "false, fictitious, and fraudulent statements" to the FDA regarding its drug data and adulterated medications.

Terence Young, Member of Parliament for Oakville, Ontario has introduced Bill C-17 (Vanessa's Law), which aims to protect Canadians from unsafe drugs. Bill C-17 is proposed as an Act to amend the Food and Drugs Act. Alongside the Plain-Language Labeling, Bill C-17 will protect Canadians who take both prescription and over-the-counter medications by requiring more comprehensive safety warnings from drug manufacturers, giving Health Canada the power to order unsafe drugs off of the Canadian market when dangers become clear, require mandatory adverse drug reaction reporting, and create a robust warning system for patients. As of September 18, 2014, Bill C-17 has undergone its Second Reading in the Senate and has been referred to the Standing Senate Committee on Social Affairs, Science and Technology.

The international community is increasingly turning to importing less-expensive pharmaceutical products from other countries. Although large-scale prescription drug importation is not currently legal in Canada or the United States, in certain circumstances, there are means by which both Canada and the United States may import pharmaceutical products. (For Canada, see here, here, and here. For US, see here, here, and here. For analysis, see here, here, and here.)

Each country has its own regulatory approaches and frameworks for all facets of pharmaceutical regulation.) Each country has its own regulatory approaches and frameworks for all facets of pharmaceutical regulation. Approaches to regulating the importation of medications is no different. In the United States, there are three important factors that aid in the determination of whether other countries can be relied upon as sources from which prescription medications may be imported:

China and India are two of the largest countries from which Canada and the United States import pharmaceutical products. The US imports approximately 40% of all over-the-counter and generic drugs produced in India. According to CNN, the United States imports 40% of its medications from India. While China resists, India allows the US Food and Drug Administration (FDA) to conduct inspections.

The FDA has inspected 160 drug plants in India since July 2012, when the US passed the Food and Drug Administration Safety and Innovation Act. These inspections have revealed that some manufacturing facilities in India have produced medications that were adulterated or contaminated, and manufacturing facilities were often filthy or invested with bugs. The FDA investigators also caught some of the Executives at these manufacturing facilities lying to them, which has led to felony charges.

On May 13, 2013, the United States Department of Justice released its statement regarding these charges. In the largest drug safety settlement with a generic drug manufacturer as of May 2013, Ranbaxy USA Inc, a subsidiary of the generic pharmaceutical manufacturer in India, Ranbaxy Laboratories Limited, pleaded guilty to felony charges with respect to the manufacturing and distribution of adultered drugs manufactured at two Ranbaxy facilities in India. Ranbaxy agreed to pay a criminal fine and forfeiture amounting to US$150 million. Ranbaxy also settled civil claims under the False Claims Act in the United States and other State laws for US$350 million. This is the largest false claims case ever prosecuted in Washington with the largest financial penalty ever paid by a generic company. US Attorney for the District of Maryland said that "[t]he joint criminal and civil settlement, which reflects many years of work by FDA agents and federal prosecutors, holds Ranbaxy accountable for a pattern of violations and should improve the reliability of generic drugs manufactured in India by Ranbaxy."

Ranbaxy distributed and sold pharmaceutical products in the United States that were manufactured at Ranbaxy facilities in Paonta Sahib, India and Dewas, India.

Ranbaxy USA, subsidiary of Ranbaxy Inc. incorporated in Delaware, enters a plea of guilty in the US.

Ranbaxy Laboratories Limited, incorporated under Indian law with headquarters in Guragaon, India, enters a Consent Decree with USA, which alleges that Ranbaxy violated US codes that prohibit (1) the introduction of adulterated drugs into interstate commerce, (2) the delivery of unapproved new drugs into interstate commerce, (3) failing to make required reports to the FDA, and (4) causing drugs to be adulterated while the drugs were for sale on the US market after shipment in interstate commerce, violating the Food, Drug and Cosmetic Act.

Individual American states entered into separate settlement agreements, referred to as Medicaid State Settlement Agreements because of Medicaid fraud allegations against Ranbaxy and allegedly engaging in (I) knowingly manufacturing, distributing, and selling in interstate commerce, (II) making false statements (including in annual reports to the FDA) about batches, lots, or portions of lots of medications imported by the US from April 1, 2003 to September 16, 2010, in which the (a) strength of medications materially differed from, or the purity or quality of which fell below the strength, purity, or quality which they were represented to possess, or (b) that were manufactured in a way that differed from its approved formulation by the FDA, making these products unapproved new drugs, in violation of the Food, Drugs and Cosmetic Act.

The US alleges that Ranbaxy knowingly caused false and/or fraudulent claims to be submitted to, or caused purchases by the Federal Health Care Programs.

According to the statement released by the United States Department of Justice, Ranbaxy USA admitted to introducing batches of adulterated drugs that were produced at Paonta Sahib in 2005 and 2006 including:

Ranbaxy was found to have incomplete testing records and an inadequate program to evaluate the stability characteristics of drugs, which were found by FDA inspections in 2006 and 2008. Ranbaxy also admitted to failing to file required FDA reports in a timely manner for batches of Sotret and gabapentin that had failed testing. Ranbaxy was also aware that certain batches of gabapentin were testing out-of-specification, possessed unknown impurities, and would not maintain their expected shelf life, between June 2007 and August 2007. Ranbaxy failed to notify the FDA and waited until October 2007 to voluntarily recall the product.

Furthermore, Ranbaxy admitted to making false, fictitious, and fraudulent statements in its required reports to the FDA in 2006 and 2007 regarding the dates of stability tests conducted on batches of:

Cefaclor,

Cefadroxil,

Amoxicillin, and

Amoxicillin and Clavulanate Potassium.

Ranbaxy reported stability test dates to the FDA which were weeks or months prior to the actual stability testing dates by Ranbaxy. Moreover, rather than conducting the stability tests at prescribed intervals, months apart, Ranbaxy conducted these tests on the same day or within a few days of each other, resulting in unreliable test results and unreliable shelf life expectations. Ranbaxy also admitted that drug samples waiting to be tested were stored for unknown periods of time in a refrigerator, which failed to meet specified temperature and humidity ranges for FDA-approved stability chambers. Ranbaxy failed to disclose this to the FDA.

Since then, the US FDA has imposed a ban on all of Ranbaxy's India-based factories.

Author:

Adrienne is currently completing her J.D. (2019) at Osgoode Hall Law School. She received her M.A. (2012) and Ph.D. (2016) in Health Policy & Equity with a focus on pharmaceutical policy, regulation, and patient safety.